Inflamm Bowel Dis. 2022 Mar 2;28(3):393-408.doi: 10.1093/ibd/izab083

Ganit Goren ¹, Doron Schwartz ^2 3, Michael Friger ⁴, Hagar Banai ^5 6, Ruslan Sergienko ³, Shirley Regev ¹, Heba Abu-Kaf ^2 3, Dan Greenberg ⁷, Anna Nemirovsky ⁶, Karny Ilan ⁸, Livnat Lerner ⁸, Alon Monsonego ⁸, Iris Dotan ^5 6, Henit Yanai ^5 6, Rami Eliakim ^6 9, Shomron Ben Horin ^6 9, Vered Slonim-Nevo ¹, Shmuel Odes ³, Orly Sarid ¹

Author information

¹Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.

²Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer Sheva, Israel.

³Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.

⁴Department of Public Health, Ben-Gurion University of the Negev, Beer Sheva, Israel.

⁵Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.

⁶Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

⁷Department of Health Systems Management, School of Public Health, Guilford Glazer Faculty of Business and Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.

⁸The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.

⁹Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel.

Abstract

Background: Patients with Crohn disease have debilitating psychological symptoms, mental fatigue, and poor quality of life. Psychological intervention may improve these symptoms.

Methods: We performed a randomized parallel-group physician-blinded trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) on quality of life and psychological symptoms in adults with mild-moderate Crohn disease. COBMINDEX was taught by social workers in one-on-one video conferences over 3 months; quotidian home practice was mandated.

Results: Fifty-five COBMINDEX and 61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women. At 3 months, COBMINDEX patients had significantly reduced disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score increased from baseline 41 to 50; P < 0.001), decreased psychological symptoms (Global Severity Index [GSI], 0.98-0.70; P < 0.001), reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, 26-33; P < 0.001), and increased mindfulness disposition (Freiburg Mindfulness Inventory, 33-38; P < 0.001). Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness. There were significant correlations (0.02 > P < 0.002) in COBMINDEX patients between baseline SIBDQ, GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores with a relative change (baseline to 3 months) of the SIBDQ score, but none among waitlist patients. Predictors of relative change of the SIBDQ score in COBMINDEX patients included the GSI score (90% quantile; coefficient 0.52; P < 0.001), somatization (90%; 0.20; P = 0.001), depression (75%; 0.16; P = 0.03), and phobic anxiety (75%; 0.31; P = 0.008).

Conclusions: COBMINDEX was effective in increasing patients' quality of life and reducing psychological symptoms and fatigue. Patients with severe baseline psychological symptoms benefited the most from COBMINDEX.